Rockeby lines up diagnostics for FDA approval
Monday, 20 September, 2004
Rockeby biomed (ASX: RBY) has lodged a 501(k) submission for regulatory approval of its systemic candidiasis diagnostic SysCan3 with the United States Food and Drug Administration.
The submission is based on data from a recent 5 centre, 200 patient clinical trial in the United States.
This data will also be used to support a second 501(k) submission for Rockeby's CanDia5 point of care diagnostic for vaginal thrush, expected later this week.
The 501(k) process -- under which the FDA determines whether the device is equivalent to devices which have already been classified -- is a much faster process than FDA approval for drugs and other pharmaceuticals and in some circumstances may take as little as 90 days from the lodgment date.
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